Works under general direction of the R&D Laboratory Manager in a c-GMP regulated manufacturing environment operating under Q7A standards.
Employees in positions at this level exercise a considerable degree of independence in conducting a wide range of analytics requiring expertise in application, adaptation of research theory, analytical techniques and instrumentation to produce desired results.
Prepare samples and conduct routine chemical analyses (Microscopy, Coulter, Mesh analysis, UV-Vis, Colorimeter, GC, HPLC, TGA, IC, AA, IR, quantitative wet chemistry, classic USP/FCC tests) daily on a self-scheduled basis but in collaboration with senior personnel.
Establish, organize, and maintain a "classic wet chemistry lab" suitable for USP/FCC/EP/ACS testing. This includes ordering chemicals, maintaining an accurate chemical inventory, standardization of titrants, preparation of frequently used test solutions, replacing expired test solutions, etc.
Support and assist senior personnel on development/improvement of analytical testing for both finished goods and in-process materials. Accurately document such procedures, protocols, and analytical methods.
Assist in QA investigations stemming from customer complaints and also out of specification product. Develop basic reprocess protocols for out of spec product. Conduct analytical testing on customer complaint material and assist in root cause analysis/corrective action.
Assist senior personnel with troubleshooting, maintenance, calibration, of analytical instrumentation including IQ, OQ and PQ.
Provides custom in-process testing and support to Production Engineers when such testing is warranted or exceeds the daily capabilities of Quality Control.
Analyzing, interpreting and reporting data including presentation of results
Maintain and enhance site safety
May perform work related to the next lower level in this series as needed
S. Chemistry or related technical field that included instrumentation
Professional level chemist experience is recommended, but not required.
Hours are during day shift with the potential for some weekend and night shifts as needed
Theories, principles, and methods of instrumental and wet chemistry
Method development and method validation
Mathematics and statistics
Basic analytical laboratory equipment
MS Office software package
Working effectively and efficiently on multiple projects at once
Working effectively in a team environment
Responding to rapidly changing demands
Follow compendia and other test methods
Develop creative solutions to more varied research procedural problems
Identify, gather, process and record data accurately
Maintain quality, safety and/or infection control standards
Operate and maintain laboratory equipment
Communicate effectively, orally and in writing (including documenting research methods, results and conclusions)